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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

FDA Plans to Release 28 Device Guidance Docs in 2015, Including on Software and Diagnostics

The US Food and Drug Administration has just released a list of all medical device guidance documents it plans to release in 2015, including ones related to speeding up device submissions, regulating lab-developed tests (LDTs) and the regulation of decision support software.

Background

The list, sometimes referred to as a "Guidance Agenda," is published on an annual basis by FDA's Center for Devices and Radiological Health, its medical device regulatory division. The list covers which guidance documents—documents which outline how FDA expects to enforce federal regulations and laws—are likely to be published in the coming fiscal year.

As in past years, the list is divided into two parts: An "A-List" of guidance documents it intends to prioritize in the coming year, and a "B-List" of documents it will publish "as resources permit."

FDA rarely, if ever, manages to publish all documents on its guidance agendas, either due to resource limitations, shifting priorities or political pushback against a proposal.

New Year, New Priorities

Among FDA's highest-priority guidance documents are several familiar to long-time industry watchers. FDA says it plans to release or finalize two documents as part of its effort to more closely regulate LDTs after releasing a draft guidance regulatory framework in August 2014. (Framework for Regulatory Oversight of Laboratory Developed Tests; FDA Notification and Medical Device Reporting for Laboratory Developed Tests)

Several new guidance documents are also set to be released in fiscal year 2015, CDRH said.

One new guidance will cover so-called "general wellness products," while another much-sought-after guidance will cover "medical device decision support software"—an area which has attracted much scrutiny for the agency.